By therapeutic solution is meant any type of product in liquid form used for a therapeutic purpose. It is generally blood components in liquid form, for example blood plasma, platelets, or packed red cells. It can be blood plasma derivatives, for example albumin or an immunoglobulin. It can also be medicamentous solutions, or also nutrient solutions. It can be glucose solution, for example 5%, G5, or also saline solutions, in particular isotonic solutions or also Ringer's solution. It can also be solutions prepared extemporaneously, in particular by adding a medicament to a bag containing a solution of a carrier fluid, typically for the treatment of diseases by intravenous route such as for the treatment of cancer.
Nowadays storage bags represent an alternative to packaging in glass vials for biotechnology products. Commonly used for the intravenous administration of perfusion solutions or for parenteral nutrition solutions or also for blood, flexible storage bags have numerous advantages, in particular that they are light and easy to handle.
Storage bags, like glass vials, are subject to very strict regulation in particular as regards their manufacture and traceability. The bags must in fact bear an inscription providing information relating to the solution, safety data such as the name of the manufacturer, the expiry date, the batch number, the recipient or also the name of the patient, ensuring in particular the traceability of the solution. The bags are generally packaged and sent to hospitals or to any recipient capable of administering the solution to a patient. The patient can himself be the recipient and self-administer the solution.
The bags currently available on the market bear an inscription made directly on a membrane defining a compartment for receiving the solution, as is the case with the flexible bag Flexbumin®, a flexible bag containing human albumin, manufactured and marketed, in particular in Sweden, by the company Baxter. The inscription can also be applied by sticking on a label on which it has been written, printed or stamped beforehand, or also by sticking on a blank label on which the information is subsequently written and/or stamped. The inscription can also be applied directly to the membrane, by handwriting typically with a felt-tip or other pen or with an ink stamp. This is the case in particular when the bag is used to administer a perfusion to a patient. It may prove that during administration the content of the bag is modified, for example by the addition of a medicament, and that the care staff then use a felt-tip pen to make an inscription indicating the modification in question, the quantity to be administered or also the time at which it must be administered.
However, molecules contained in the ink and/or the adhesive used can pass through the membrane and migrate into the therapeutic solution. Such molecules are capable of being toxic to the recipient or of modifying the properties of the solution. Their presence is therefore undesirable and must be avoided. Moreover, the material constituting the membrane is capable of being damaged when the inscription is applied due to the fact that molecules can dissociate from the membrane and contaminate the solution. This contamination of the solution and/or damage to the membrane can be particularly significant in the case where an inscription is applied by hand-writing with a felt-tip or other pen directly on the membrane or on a blank label stuck to the membrane beforehand.
Flexible storage bags are described in Baxter's Patent Application WO 02/072429 and U.S. Pat. No. 4,654,240. Patent Application WO 02/072429 describes a flexible polymeric bag for storing a solution of peptides and/or proteins, as well as a method for introducing such a solution into a flexible polymeric container. The manner in which an inscription is applied to the storage bag is not mentioned in this document. U.S. Pat. No. 4,654,240 describes a laminate film material for a flexible bag capable of storing a product having to be maintained and extracted under sterile conditions. The bag is optionally sterilized with steam. The manner in which an inscription is applied to the storage bag is also not mentioned in this document.
A solution for reducing the risk of contamination in the case where the inscription is applied to the membrane consists of using a particular ink the molecules of which have more difficulty in passing through the membrane. However, such an ink is expensive. Moreover, this solution does not sufficiently reduce the risk of contamination as ink molecules continue to pass through the membrane, and the membrane can always be damaged. Finally, this solution does not address the risk of contamination linked to the inscription applied by sticking on a label. A need therefore exists to reinforce the safety of the batches of therapeutic solution. By means of the present invention the Applicant has surprisingly developed a bag for storing a therapeutic solution, improving the safety linked to the therapeutic solution, and allowing an inscription to be applied to it whilst reducing the risk of contamination.